Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil IV: Methodische Aspekte, Diskussion und Empfehlungen

Objective: Empirical investigation of the influence of patient self-selection during follow-up in a prospective observational study in 4 in-patient facilities for complementary medicine and discussion of further methodological problems. Methods: 2662 patients treated in the 4 hospitals and included in a prospective observational study had been sent follow-up questionnaires 2, 6, and 12 months after admission. Characteristics and therapeutic success at discharge were compared in patients responding and those not responding. Results: Patients not responding to the follow-up questionnaires tended to be older and to assess the benefit of the treatment less positive than patients who responded (hospital one: 56.2% of patients with a follow-up reported a good or very good response to therapy at discharge compared to 37.7% of the patients without a follow-up: hospital two: 63.7% vs. 54.6%; hospital three: 71.1% vs. 65.8%; hospital four: 78,3% vs. 70,9%). Interpretation: When interpreting the results of the observational study a certain degree of bias induced by selection during follow-up has to be taken into account. Discussion: Other methodological problems discussed narratively include spontaneous improvements, reliability of baseline measures, influence of effective cointerventions, side-effects, outcome measures, feasibility, and efficiency. Finally, recommendations for quality management programs in in-patient facilities for complementary medicine are provided

Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil III: Zwischenergebnisse der diagnosespezifischen Dokumentation Migräne in der Klinik für TraditionelleChinesische Medizin Kötzting

Objective: To evaluate the course of symtoms and quality of life of migraine patients after treatment with traditional Chinese medicine. Design: Prospective observational study with 12 months follow-up. Patients: 138 consecutive patients diagnosed by a neurologist to have migraine headaches. Intervention: Complex in-patient treatment with traditional Chinese medicine including acupuncture and Chinese drug therapy. Outcomes: Number of days with headaches per month, number, intensity and duration of migraine attacks, concomitant symptoms, quality of life, global assessment and days off work. Results: The number of days with headaches per month decreased from 9 (median) at baseline to 4 at discharge and was 3 at 12 months. Also, for the other outcomes a clear improvement was seen with a slight wash-out tendency in follow-up. Conclusion: The observed patients with long-lasting migraines had a marked benefit from an in-patient treatment with traditional Chinese medicine

Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil II: Detaillierte Ergebnisse der Klinik für Traditionelle ChinesischeMedizin Kötzting

Objective: To collect information on patients, interventions and outcomes in a hospital for traditional Chinese medicine in Germany. Design: Prospective observational study with 12 months followup. Patients: All 667 consecutive patients admitted for in-patient treatment in the hospital between December 1994 and July 1995 were documented. The follow-up rate after 12 months was 65.8%. Outcome Measures: Sociodemographic data, diagnoses, duration of complaints, type and frequency of diagnostic and therapeutic interventions, intensity of complaints, assessment of the therapeutic success and quality of life. Results: About two thirds of the patients suffered from chronic pain syndromes (the most frequent single diagnoses were migraine, lumbago, and neck pain/headaches). 72.3% of the patients were female; the median duration since the onset of the disease was 7 years. Almost all patients received acupuncture and treatment with traditional Chinese drugs. 50.3% assessed the therapeutic success as good or very good at discharge; after 12 months this rate was 55.6%. Both intensity of main complaints and psychic and physical aspects of quality of life improved after treatment. After 12 months the improvement was less distinct but still significant. Conclusions: The in-patient treatment provided a clear benefit to the patients. Without a valid comparison with an alternative treatment little can be concluded about comparative effectiveness and efficiency of a treatment in the hospital for traditional Chinese medicine

Use of Chinese drugs in patients with metabolic syndrome in a German TCM hospital

Background/objectives: In Traditional Chinese Medicine (TCM) drug treatment usually is given as prescription including multiple drugs. The prescription is highly individualized according to specific configurations of TCM syndromes. The analysis is to provide an overview of frequently or rarely used combinations of single drugs in a German TCM hospital, and how to compare such patterns in two clinical patient subgroups. Methods: Based on a sample of 2,129 in-patients (71% female, age 53.5±14.3 yrs) of the TCM hospital Bad Kötzting, Germany, the relative frequencies of 221 single drugs prescribed at the beginning of the treatment were analysed. Patients who fulfilled the criteria for Metabolic Syndrome (MetS) were compared with those patients who did not. Univariate and multivariate statistical models like logistic regression, factor and cluster analyses were applied. Results: Astragali radix was identified as the most frequently prescribed single drug in 47.1% of the patients. One prescription comprised 12 single drugs, on average. The frequency of use differed mostly in patients with or without MetS with respect to Chaenomelis fructus and Spatholobi caulisor (more frequent in MetS), and Bupleuri radix and Poria (less frequent in MetS). Angelicae pubescentis radix was prescribed more often in MetS while for Angelicae sinensis radix it was the opposite. Factor analysis indicated that some combinations of drugs exist which could be empirically confirmed in a subgroup analysis (two clusters of patients) with however, limited specificity regarding MetS. Conclusions: Use of multivariate analyses is essential when patterns of single drugs in TCM are to be explored. The results provide indications for different prescriptions in patients with MetS compared to those without. Dislosure: Author of abstracts, with publication of this abstract, hereby claims that is not a plagiarism and that it is not related with any commercial, propaganda or advertising purposes

Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil I: Methoden und Übersicht der Ergebnisse in den beteiligten Kliniken

Background: In Germany a considerable number of in-patient facilities offer complementary medicine in addition to conventional care. In this study we aimed to describe patient characteristics, diagnostics, therapy and outcomes of four such in-patient facilities. Methods: 2835 consecutive in-patients admitted to two private hospitals with an emphasis on complementary medical cart, one private hospital for traditional Chinese medicine, and the Department of Complementary Medicine of a public district hospital participated in a prospective observational (cohort) study with 12 months follow-up. Sociodemographic characteristics, diagnoses, duration of disease, type and frequency of therapeutic interventions, intensity of complaints, assessment of therapeutic success, and quality of life were documented. Results: Patients of the observed hospitals were mostly female (66%-80% in the four hospitals) and a high proportion was chronically ill (31%-62% with a disease history longer than 5 years). The frequency of single diagnoses varied strongly between the four hospitals, however, chronic pain syndromes were very frequent in all. Complementary care always included a large number of different therapeutic methods whose combination varied with different diagnoses and between the hospitals. At discharge, 57%-73% of patients rated the therapeutic success as good or very good, Follow-up rates were satisfactory only in two of the four hospitals. After 12 months 51%-64% of the responding patients still rated the success as good or very good. Conclusions: In the observed hospitals mainly chronically ill patients are treated with highly complex combinations of a large variety of complementary therapies. A majority of patients seems to be satisfied by the treatment. A major methodological problem in the interpretations of patient outcomes are the partly low followup rates

Profiling quality of care for patients with chronic headache in three different German hospitals – a case study

BACKGROUND: Legal requirements for quality assurance in German rehabilitation hospitals include comparisons of providers. Objective is to describe and to compare outcome quality of care offered by three hospitals providing in-patient rehabilitative treatment exemplified for patients with chronic headache. METHODS: We performed a prospective three center observational study on patients suffering from chronic headache. Patients underwent interventions commonly used according to internal guidelines of the hospitals. Measurements were taken at three points in time (at admission, at discharge and 6 months after discharge). Indicators of outcome quality included pain intensity and frequency of pain, functional ability, depression, quality of life and health related behavior. Analyses of differences amongst the hospitals were adjusted by covariates due to case-mix situation. RESULTS: 306 patients from 3 hospitals were included in statistical analysis. Amongst the hospitals, patients differed significantly in age, education, diagnostic subgroups, beliefs, and with respect to some pain-related baseline values (covariates). Patients in all three hospitals benefited from intervention to a clinically relevant degree. At discharge from hospital, outcome quality differed significantly after adjustment according to case-mix only in terms of patients' global assessment of treatment results. Six months after discharge, the only detectable significant differences were for secondary outcomes like improved coping with stress or increased use of self-help. The profiles for satisfaction with the hospital stay showed clear differences amongst patients. CONCLUSION: The results of this case study do not suggest a definite overall ranking of the three hospitals that were compared, but outcome profiles offer a multilayer platform of reliable information which might facilitate decision making

Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669)

Background Musculoskeletal pain is a major contributor to short and long term work absence. Patients seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with work issues. Providing a vocational case management service in primary care, to support patients with musculoskeletal problems to remain at or return to work, is one potential solution but requires robust evaluation to test clinical and cost-effectiveness. Methods/Design This protocol describes a cluster randomised controlled trial, with linked qualitative interviews, to investigate the effect of introducing a vocational advice service into general practice, to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work. General practices (n = 6) will be randomised to offer best current care or best current care plus a vocational advice service. Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited. Data collection will be through patient completed questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits. A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs, nurse practitioners (NPs), patients and vocational advisors. Discussion This paper presents the rationale, design, and methods of the Study of Work And Pain (SWAP) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues. Trial registration Current Controlled Trials ISRCTN52269669

Predictors of outcome after 6 and 12 months following anthroposophic therapy for adult outpatients with chronic disease: a secondary analysis from a prospective observational study

<p>Abstract</p> <p>Background</p> <p>Anthroposophic medicine is a physician-provided complementary therapy system involving counselling, artistic and physical therapies, and special medications. The purpose of this analysis was to identify predictors of symptom improvement in patients receiving anthroposophic treatment for chronic diseases.</p> <p>Methods</p> <p>913 adult outpatients from Germany participated in a prospective cohort study. Patients were starting anthroposophic treatment for mental (30.4% of patients, n = 278/913), musculoskeletal (20.2%), neurological (7.6%), genitourinary (7.4%) or respiratory disorders (7.2%) or other chronic indications. Stepwise multiple linear regression analysis was performed with the improvement of Symptom Score (patients' assessment, 0: not present, 10: worst possible) after 6 and 12 months as dependent variables. 61 independent variables pertaining to socio-demographics, life style, disease status, co-morbidity, health status (SF-36), depression, and therapy factors were analysed.</p> <p>Results</p> <p>Compared to baseline, Symptom Score improved by average 2.53 points (95% confidence interval 2.39-2.68, p < 0.001) after six months and by 2.49 points (2.32-2.65, p < 0.001) after 12 months. The strongest predictor for improvement after six months was baseline Symptom Score, which alone accounted for 25% of the variance (total model 32%). Improvement after six months was also positively predicted by better physical function, better general health, shorter disease duration, higher education level, a diagnosis of respiratory disorders, and by a higher therapy goal documented by the physician at baseline; and negatively predicted by the number of physiotherapy sessions in the pre-study year and by a diagnosis of genitourinary disorders. Seven of these nine variables (not the two diagnoses) also predicted improvement after 12 months. When repeating the 0-6 month analysis on two random subsamples of the original sample, three variables (baseline Symptom Score, physical function, general health) remained significant predictors in both analyses, and three further variables (education level, respiratory disorders, therapy goal) were significant in one analysis.</p> <p>Conclusion</p> <p>In adult outpatients receiving anthroposophic treatment for chronic diseases, symptom improvement after 6 and 12 months was predicted by baseline symptoms, health status, disease duration, education, and therapy goal. Other variables were not associated with the outcome. This secondary predictor analysis of data from a pre-post study does not allow for causal conclusions; the results are hypothesis generating and need verification in subsequent studies.</p

Use of complementary alternative medicine for low back pain consulting in general practice: a cohort study

<p>Abstract</p> <p>Background</p> <p>Although back pain is considered one of the most frequent reasons why patients seek complementary and alternative medical (CAM) therapies little is known on the extent patients are actually using CAM for back pain.</p> <p>Methods</p> <p>This is a post hoc analysis of a longitudinal prospective cohort study embedded in a RCT. General practitioners (GPs) recruited consecutively adult patients presenting with LBP. Data on physical function, on subjective mood, and on utilization of health services was collected at the first consultation and at follow-up telephone interviews for a period of twelve months</p> <p>Results</p> <p>A total of 691 (51%) respectively 928 (69%) out of 1,342 patients received one form of CAM depending on the definition. Local heat, massage, and spinal manipulation were the forms of CAM most commonly offered. Using CAM was associated with specialist care, chronic LBP and treatment in a rehabilitation facility. Receiving spinal manipulation, acupuncture or TENS was associated with consulting a GP providing these services. Apart from chronicity disease related factors like functional capacity or pain only showed weak or no association with receiving CAM.</p> <p>Conclusion</p> <p>The frequent use of CAM for LBP demonstrates that CAM is popular in patients and doctors alike. The observed association with a treatment in a rehabilitation facility or with specialist consultations rather reflects professional preferences of the physicians than a clear medical indication. The observed dependence on providers and provider related services, as well as a significant proportion receiving CAM that did not meet the so far established selection criteria suggests some arbitrary use of CAM.</p